Collagenase Clostridium Histolyticum for the Treatment of Edematous Fibrosclerotic Panniculopathy (Cellulite): A Randomized Trial.

Abstract

BACKGROUND:

Edematous fibrosclerotic panniculopathy (EFP; cellulite) is associated with thickening and contraction of collagen-rich subdermal septae. Collagenase clostridium histolyticum (CCH) may disrupt collagen-rich septae.

OBJECTIVE:

To evaluate the safety and efficacy of CCH for treatment of EFP.

MATERIALS AND METHODS:

In a randomized, double-blind study, women with moderate or severe EFP of the buttocks or posterolateral thighs (i.e., Clinician Reported Photonumeric Cellulite Severity Scale [CR-PCSS] and Patient Reported Photonumeric Cellulite Severity Scale [PR-PCSS] ratings of 3 to 4, and Hexsel Cellulite Severity Scale score ≤13) received up to 3 treatment sessions (Days 1, 22, and 43) of subcutaneous CCH 0.84 mg or placebo injections. End points included the percentage of 2-level and 1-level composite responders (i.e., had ≥2-level or ≥1-level improvement in CR-PCSS and PR-PCSS) at Day 71.

RESULTS:

Three hundred seventy-five women (mean age, 46.5 years; 86.4% white) were randomly assigned to CCH (n = 189) or placebo (n = 186). At Day 71, the percentages of 2-level and 1-level composite responders were greater with CCH (10.6% and 44.6%, respectively) versus placebo (1.6% and 17.9%; p < .001 for both). The most common adverse events were injection-site related.

CONCLUSION:

CCH significantly improved EFP appearance versus placebo; further evaluation of CCH for EFP (cellulite) is warranted.

• Authors: Neil S Sadick, Mitchel P Goldman, Genzhou Liu, Neil H Shusterman, Michael P McLane, David Hurley, V Leroy Young
• Journal: Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] (Dermatol Surg) Vol. 45 Issue 8 Pg. 1047-1056 (08 2019) ISSN: 1524-4725 [Electronic] United States
• PMID: 30829779 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Microbial Collagenase

Topics

• Buttocks
• Cellulite (drug therapy)
• Double-Blind Method
• Edema (drug therapy)
• Female
• Humans
• Injections, Intralesional
• Microbial Collagenase (therapeutic use)
• Middle Aged
• Severity of Illness Index
• Thigh